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MEDICAL DEVICE RECALLMODERATE
MAC 5 Resting ECG Analysis Systems
GE is recalling MAC 5 A4 and A5 ECG systems due to a software error that may incorrectly associate clinical data with the wrong patient.
What to do
Contact your GE Healthcare representative or service provider to arrange for a software update to the correct production version.
Why it was recalled
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
How to identify it
MAC 5 A4 Resting ECG Analysis System 855001-001;
Official source
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Editorial summary by Recall Canary · last updated 2026-06-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification